Module

Clinical Development

The Clinical Development program at Paul Janssen Futurelab Leiden provides “learning-by-doing” training to ambitious postgraduate biomedical researchers who wish to further their career and increase their knowledge on the development of novel medical interventions. The program focuses on several important aspects associated with the development medicinal products, medical devices, and medical nutrition products. The Clinical Development program consists of three sequential courses:

The Paul Janssen Futurelab Leiden uses (amongst others) teaching case studies that are (in part) based on real-life cases. At the end of the session we reveal the results that occurred in real-life for the case. We herewith kindly request you not to reveal the content and the outcomes of the cases to others outside the course, to ensure that the learning experience for future course participants is not spoiled. As part of this policy, some course material can’t be downloaded or printed, but can be viewed from the Paul Janssen Futurelab Leiden website only.

Statement*

I have read and understand the statement above and agree not to reveal the content of the teaching case studies and the outcomes to others outside the course.

Clinical Development On-campus Extended

This 5-day On-campus Extended Futurelab course follows from the 4-day On-campus. In this course, you will work with a mentor (a clinical expert) to develop your own clinical trial based on the brief pre-proposal that you submitted with your application. In addition, your mentor will guide you through the scientific and practical challenges associated with drafting a clinical trial application, this course takes place in Leiden, the Netherlands.

Learning outcomes

Upon completing this course, you will be able to take a preliminary idea for a novel medical intervention and turn it into a fully developed clinical trial protocol. In addition, you will have a clear understanding of what constitutes a complete research file ready to be submitted to the appropriate authorities and research ethics committees.

Application procedure for this course

The number of spaces is limited. Therefore, applicants will be selected based on their application for the On-campus course, as well as their pre-proposal for the clinical trial to be developed during On-campus Extended. Note that participants for this course must first successfully complete both the Online course and the On-campus course.

€500,000 grant for the best clinical trial application

A highly competitive €500,000 grant from the Dutch funding agency ZonMw is available for the best clinical trial application developed during this course, for testing a registered medicinal product in a Dutch research institute or hospital. Paul Janssen Futurelab Leiden will review all developed clinical trial applications during this course and award the best proposal with a nomination letter that can be used for obtaining the ZonMw grant.

Requirements

successful application for this course

successful completion of the Clinical Development Online course

a Good Clinical Practice certificate (or equivalent) within four years of applying for this course

Please use the template below to provide a short summary of your proposed clinical trial

Download template Summary Proposal

A highly competitive €500,000 grant from the Dutch funding agency ZonMw is available for the best clinical trial application developed during this course for a clinical trial with a registered medicinal product to be conducted in a Dutch research institute or hospital. Paul Janssen Futurelab Leiden will review all developed clinical trial applications during this course and award the best proposal with a nomination letter that can be included in the application for the ZonMw grant.

ZonMw grant of €500,000

I would like to join the competition for the Nomination letter to obtain the ZonMw grant.

Yes, I'm joining the competition

Download template Letter of Department Head

The Paul Janssen Futurelab Leiden uses (amongst others) teaching case studies that are (in part) based on real-life cases. At the end of the session we reveal the results that occurred in real-life for the case. We herewith kindly request not to reveal the content and the outcomes of the cases to others outside the course, to ensure that the learning experience for future course participants remains intact. As part of this policy, some course material can’t be downloaded or printed, but can be viewed from the Paul Janssen Futurelab Leiden website only.

Statement*

I have read and understand the statement above and agree not to reveal the content of the teaching case studies and the outcomes to others outside the course.